A closure system particularly for peritoneal dialysis catheters is currently marketed by the Quinton Instrument Company under the name Beta-Cap and Beta-Cap II. In this closure system, a self-sterilizing luer lock cap and adaptor is provided in which a handle member is positioned just behind the connector, and a cap with a stylet projects into the bore of the catheter. The catheter or set is temporarily sealed, typically with a clamp a short distance away from the connector. The bore of the connector is filled with an antiseptic such as povidone iodine. The cap is applied, with the stylet forcing antiseptic from the bore outwardly to spill about the outer surfaces of the connector as the cap is secured into sealing relation, and the connector is stored in this manner until it is ready for use.
A possible disadvantage of this system is the insertion of a stylet and an antiseptic tube into the bore of the catheter or set. The catheter or set before disconnection or uncapping is generally essentially sterile in its interior. Furthermore, antiseptic is applied with a needle-nosed tubular applicator which reaches down into the bore of the connector and tubing as close to the clamp as possible. The applicator is then withdrawn as the antiseptic is dispensed. The use of a non-sterile, needle-nosed applicator introduces contamination that otherwise would not be there.
The projecting, exposed stylet of the cap must pass through the atmosphere, where it possibly may pick up contamination. Accordingly, the very act of inserting the stylet or antiseptic applicator into the bore of the catheter or set may drive contamination into the bore.
At the same time, there is no guarantee that an air bubble where antiseptic has not reached will not remain in the bore of the catheter or set. This does not necessarily represent a serious problem, since the catheter or set starts out substantially sterile, and it is to be expected that the inner wall, in contact with an internal air bubble fairly deep within the set, will remain so. However, the stylet driving into the bore may well drive contamination into the air bubble, where it is not as effectively dealt with by the antiseptic in the system.
Furthermore, the outer surfaces of the connector in the above-described closure system may not be sterilized. Particularly in the event where screw threads are used it would be desirable to have a system to permit the substantial sterilization of that area by thorough contact with flowing liquid antiseptic.
Quinton U.S. Pat. No. 3,484,121 discloses a cannula extension and connector apparatus for the connection of two catheters and the like. The use of antiseptic is not taught therein.
The word "sterile" as used herein is intended to include not only its accustomed meaning of a total absence of living microorganisms, but also is intended to include the concept of substantial sterility, in which the number of microorganisms is reduced to such a low population that the likelihood of infection or contamination, i.e., peritonitis in the case of CAPD, is substantially reduced or eliminated.